IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)

K063328 · Imc-Heart Way LLC · ITI · Apr 27, 2007 · Physical Medicine

Device Facts

• Record ID: K063328
• Device Name: IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
• Applicant: Imc-Heart Way LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Device Story

IMC Heartway Model-Allure (HP6) is an electric power wheelchair designed for adult mobility. Device input consists of user-operated joystick commands; internal controller transforms these inputs into motor-driven movement. Output is physical displacement of the wheelchair. Intended for use by patients with sufficient upper-body dexterity to operate controls and ability to self-transfer to a seated position. Device provides independent mobility for users with physical impairments. Operated by the patient in various environments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electric power wheelchair; joystick-controlled motor system; weight capacity up to 350 lbs; standard powered wheelchair form factor.

Indications for Use

Indicated for adults up to 350 lbs requiring mobility assistance who can independently sit in the wheelchair and operate a standard joystick hand control.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

IMC-Heartway, LLC % Mr. Michael Chen President 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912

Re: K063328

Trade/Device Name: IMC Heartway Model-Allure (HP6), Electric Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 16, 2007 Received: April 17, 2007

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent ffor the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 – Mr. Michael Chen

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number : K063328

Device Name: IMC Heartway Model-Allure (HP6), Electric Power Wheelchair

Indications for Use: The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Prescription Use (Part 21CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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*(Division Sign-Off)*
Division of General, Restorative

Division of General, Restorative, and Neurological Devices

063328

710(k) Number

7